11 completed, 5 terminated, 2 unknown. 10 Phase 2, 6 Phase 1, 3 Phase 4, 1 Early Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 10 | Completed 8, Terminated 1, Unknown 1 |
| Phase 1 | 6 | Completed 3, Terminated 3 |
| Phase 4 | 3 | Completed 1, Terminated 1, Unknown 1 |
| Early Phase 1 | 1 | Completed 1 |
| Phase 3 | 1 | Terminated 1 |
Follow zileuton: new trials by email Literature Review of zileuton trials Research Report on zileuton
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial Oxcarbazepine, Carbamazepine - Trigeminal Neuralgia | Phase 4 | Unknown | Postgraduate Institute of Dental Sciences Rohtak | 132 | 2021-09-18 | 2021-10-15 |
| Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers Aspirin, Laboratory Biomarker Analysis, Placebo Administration - Tobacco Use Disorder | Phase 2 | Completed | National Cancer Institute (NCI) | 63 | 2016-01-13 | 2022-06-02 |
| Evaluating the Safety of Zileuton (Zyflo®) in Combination With Dasatinib (Sprycel®) in Chronic Myelogenous Leukemia Zileuton (Zyflo®) Dasatinib (Sprycel®), Dosing with Zileuton/Dasatinib in CML, Daily dosing of Zileuton/Dasatinib - Chronic Myelogenous Leukemia | Phase 1 | Terminated | University of Massachusetts, Worcester | 2 | 2014-01-01 | 2016-09-30 |
| Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging Zileuton, Pioglitazone placebo, Zileuton placebo - Lung Inflammation | Early Phase 1 | Completed | Washington University School of Medicine | 39 | 2011-07-01 | 2014-04-23 |
| Trial of Zileuton CR in Children and Adults With Sickle Cell Disease Zileuton - Sickle Cell Disease | Phase 1 | Completed | Children's Hospital Medical Center, Cincinnati | 9 | 2010-09-01 | 2014-06-18 |
| Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers Zileuton, Celecoxib, laboratory biomarker analysis - Tobacco Use Disorder | Phase 1 / Phase 2 | Completed | National Cancer Institute (NCI) | 84 | 2010-05-01 | 2015-04-02 |
| Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML. Zileuton - Chronic Myelogenous Leukemia | Phase 1 | Terminated | University of Massachusetts, Worcester | 2 | 2010-01-01 | 2015-05-27 |
| PF-04191834 Single Dose Bronchodilatory Study In Asthma. PF-04191834, zileuton, Placebo - Asthma | Phase 2 | Completed | Pfizer | 15 | 2008-07-01 | 2013-02-01 |
| Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients zileuton, placebo - Asthma | Phase 2 | Completed | Critical Therapeutics | 36 | 2007-09-01 | 2008-03-21 |
| Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICS Zileuton CR, Placebo - Asthma | Phase 4 | Terminated | Critical Therapeutics | 400 | 2007-07-01 | 2008-04-03 |
| Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome Losartan, Zileuton, N-Acetylcysteine - Hermansky-Pudlak Syndrome (HPS), Pulmonary Fibrosis | Phase 1 / Phase 2 | Terminated | National Human Genome Research Institute (NHGRI) | 3 | 2007-04-01 | 2013-08-02 |
| Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study) Zileuton, Placebo - Pulmonary Disease, Chronic Obstructive | Phase 3 | Terminated | University of Minnesota | 119 | 2007-03-01 | 2019-11-18 |
| Safety Study of Zileuton Injection in Patients With Asthma Zileuton injection - Asthma | Phase 1 / Phase 2 | Completed | Critical Therapeutics | 60 | 2006-01-01 | 2007-09-26 |
| Zileuton and Exhaled Nitric Oxide in Asthmatics zileuton - Asthma | Phase 4 | Completed | Gelb, Arthur F., M.D. | 19 | 2005-09-01 | 2007-12-20 |
| Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris Zileuton - Acne Vulgaris | Phase 2 | Unknown | Critical Therapeutics | 90 | 2004-11-01 | 2007-02-07 |
| Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer carboplatin, celecoxib, gemcitabine hydrochloride - Lung Cancer | Phase 2 | Completed | Alliance for Clinical Trials in Oncology | 140 | 2003-12-01 | 2016-06-30 |
| Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia zileuton - Head and Neck Cancer, Lung Cancer | Phase 2 | Completed | Barbara Ann Karmanos Cancer Institute | 38 | 2003-06-01 | 2013-04-29 |
| Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis zileuton, azathioprine/prednisone - Idiopathic Pulmonary Fibrosis | Phase 2 | Completed | University of Michigan | 44 | 2001-01-01 | 2015-12-03 |
Asthma (5) · Carcinoma, Non-Small-Cell Lung (2) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive (2) · Lung Neoplasms (2) · Tobacco Use Disorder (2) · Acne Vulgaris (1) · Adenocarcinoma of Lung (1) · Albinism (1) · Albinism, Oculocutaneous (1) · Anemia, Sickle Cell (1) · Asthma, Exercise-Induced (1) · Head and Neck Neoplasms (1) · Hermanski-Pudlak Syndrome (1) · Idiopathic Pulmonary Fibrosis (1) · Inflammation (1)
Critical Therapeutics (4) · National Cancer Institute (NCI) (2) · University of Massachusetts, Worcester (2) · Alliance for Clinical Trials in Oncology (1) · Barbara Ann Karmanos Cancer Institute (1) · Children's Hospital Medical Center, Cincinnati (1) · Gelb, Arthur F., M.D. (1) · National Human Genome Research Institute (NHGRI) (1) · Pfizer (1) · Postgraduate Institute of Dental Sciences Rohtak (1) · University of Michigan (1) · University of Minnesota (1) · Washington University School of Medicine (1)
United States (16) · India (1)
Jan Cerny, MD, PhD (2) · Cornelis Wortel, MD, PhD (1) · Dana Hilt, MD (1) · Delphine L Chen, MD (1) · Dr. Cees Wortel (1) · Galen B Toews, MD (1) · Linda L Garland (1) · Martin Edelman, MD (1) · Omer Kucuk, MD (1) · Powel Brown, MD (1) · Prescott Woodruff, MD (1) · Punam Malik, MD (1) · Thomas Markello, M.D. (1) · Walter Newman, Ph.D. (1)
PMID 17151364, PMID 18281656, PMID 19467341, PMID 19503090, PMID 21299475, PMID 29414995
N01CN00031 (1), N01CN35159 (1), P30CA022453 (1), P30CA023074 (1), P50HL056402 (1), U10CA031946 (1), U10HL074424 (1)